AMCP Research Rundown — FDA-Funded Project to Inform Interchangeable Biosimilar Approvals

What’s AMCP Research Institute (ARI) been working on lately? We've been working on the BBCIC FDA-funded project, Bridging the Gap: Using Foreign Real-World Data to Inform Interchangeable Biosimilar Approvals.

This study explores how real-world data from outside the United States can help inform regulatory decision-making for biosimilars. By evaluating data sources from Italy and Denmark, the team is assessing how international real-world evidence can support biosimilar research and answer key regulatory questions.

Last week, AMCP Principal Research Scientist Pam Pawloski, PharmD, BCOP, FCCP, presented a project poster at ISPE 2026 in Milan, where she and Cate shared early findings and connected in person with our research collaborators from Italy and Denmark. 

These international partnerships have been instrumental to the project and will help inform recommendations on how foreign real-world data may support future biosimilar regulatory assessments.

As the project wraps up, the team is preparing for a close-out meeting with FDA colleagues on September 29. We look forward to sharing more about the findings and impact of this work soon!

As always, feel free to reach out to the AMCP Research Institute team with any questions about ARI’s work.

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Julia Marsh
Director, Projects & Operations
Published on September 11, 2026